Comprehensive Guide to Conducting Design Reviews for Medical Devices
1) Purpose
The purpose of this SOP is to define a structured process for conducting design reviews during the development of medical devices. Design reviews ensure that the device meets user needs, safety standards, and regulatory requirements while identifying and addressing potential issues early in the development process.
2) Scope
This SOP applies to all medical devices under development, covering all stages of design, including concept, detailed design, and final validation. It is relevant to product development, engineering, quality assurance, and regulatory affairs teams.
3) Responsibilities
– Product Development Team: Prepares design documentation and presents designs for review.
– Design Review Team: Evaluates the design, identifies risks, and suggests improvements.
– Quality Assurance (QA): Ensures compliance with design controls and regulatory requirements.
– Regulatory Affairs: Verifies alignment with applicable standards and guidelines.
– Document Control Team: Maintains records of design review meetings and outcomes.
4) Procedure
4.1 Planning Design Reviews
4.1.1 Establishing Review Phases
– Schedule design reviews at key development milestones, including:
– Concept Review: Evaluate the feasibility of initial designs.
– Detailed Design Review: Assess detailed specifications and technical drawings.
– Final Design Review: Confirm readiness for
4.1.2 Assembling the Review Team
– Form a multidisciplinary review team comprising:
– Product designers and engineers.
– QA and risk management representatives.
– Regulatory experts.
– Clinical advisors (if necessary).
– Assign a chairperson to facilitate the review process.
4.2 Conducting the Design Review
4.2.1 Preparing for the Review
– Provide all team members with relevant design documentation in advance, such as:
– User needs and requirement specifications.
– Risk assessments and hazard analyses.
– Functional and technical specifications.
– Prototypes, models, or simulations.
4.2.2 Review Meeting Agenda
– Structure the meeting as follows:
– Introduction: Define the purpose and objectives of the review.
– Presentation: Product development team presents the design.
– Evaluation: Team evaluates the design against requirements and identifies risks.
– Discussion: Team discusses findings, suggestions, and corrective actions.
– Conclusion: Summarize outcomes and agree on next steps.
4.2.3 Evaluation Criteria
– Evaluate the design based on:
– Compliance with user needs and functional specifications.
– Risk management considerations (e.g., ISO 14971 compliance).
– Feasibility of manufacturing and production.
– Adherence to regulatory requirements (e.g., FDA, EU MDR).
4.3 Documenting the Design Review
4.3.1 Review Summary Report
– Document the following in a Design Review Report:
– Date, time, and location of the review.
– Names and roles of participants.
– Key discussion points and identified issues.
– Decisions made and actions assigned.
– Ensure the report is reviewed and approved by the team.
4.3.2 Action Items and Follow-Up
– Record action items, including:
– Specific issues to be addressed.
– Assigned responsibilities.
– Deadlines for resolution.
– Track progress and ensure closure of all actions before proceeding to the next phase.
4.4 Managing Changes and Updates
4.4.1 Revisiting Design Reviews
– Conduct additional reviews if:
– Significant design changes occur.
– New risks or regulatory updates are identified.
– Update the review summary report and associated documentation as needed.
4.4.2 Change Control
– Log design changes in the Change Control Log and assess their impact on:
– Design outputs.
– Risk management plans.
– Validation and verification processes.
4.5 Verification and Validation
4.5.1 Design Verification
– Confirm that design outputs meet input requirements through:
– Prototype testing.
– Simulation studies.
– Inspection of technical drawings.
4.5.2 Design Validation
– Validate that the final product fulfills user needs and intended use through:
– Clinical evaluations.
– Usability testing.
– Real-world performance monitoring.
4.5.3 Traceability
– Maintain a traceability matrix linking design inputs, outputs, and review findings.
4.6 Documentation and Record Keeping
4.6.1 Design Review File
– Maintain a file containing:
– Design Review Reports.
– Action Item Logs.
– Change Control Logs.
– Validation and verification records.
– Ensure version control and secure access to documents.
4.6.2 Retention Period
– Retain design review records for a minimum of five years or as required by regulatory bodies.
5) Abbreviations
– FDA: Food and Drug Administration
– EU MDR: European Medical Device Regulation
– QA: Quality Assurance
– SOP: Standard Operating Procedure
– ISO: International Organization for Standardization
6) Documents
– Design Review Report
– Action Item Log
– Change Control Log
– Traceability Matrix
– Validation and Verification Records
7) Reference
– FDA CFR Title 21, Part 820: Design Controls
– ISO 14971: Application of Risk Management to Medical Devices
– ISO 13485: Medical Devices – Quality Management Systems
– EU MDR (Regulation (EU) 2017/745): General Safety and Performance Requirements
8) SOP Version
– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]
Annexure
Annexure 1: Design Review Report Template
| Date | Design Phase | Participants | Key Findings | Action Items |
|---|---|---|---|---|
| DD/MM/YYYY | Concept Review | Development Team, QA, Regulatory | Material selection requires review | Identify alternatives by next meeting |
Annexure 2: Action Item Log Template
| Action ID | Description | Assigned To | Deadline | Status |
|---|---|---|---|---|
| AI-001 | Update design to improve durability | Engineering Team | DD/MM/YYYY | In Progress |